Status:
COMPLETED
Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine, topotecan, vinorelbine, thiotepa, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells ...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of clofarabine when administered in combination with topotecan hydrochloride, vinorelbine ditartrate, thiotepa, and dexamethasone in young patients ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Must have 1 of the following diagnoses:
- Acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:
- Refractory to initial induction with two or more standard regimens
- Relapsed \< 24 months after first complete response on a high-risk protocol OR refractory to one standard reinduction regimen
- Second or greater relapse
- Acute myeloid leukemia, acute biphenotypic leukemia, or acute undifferentiated leukemia meeting 1 of the following criteria:
- Refractory to initial induction
- First or greater relapse
- Must have \> 20% bone marrow blasts, or evidence of recurrent disease at an extramedullary site
- No symptomatic CNS disease
- Patients with asymptomatic CNS disease are eligible with the approval of the principal investigator
- PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 70-100% OR Lansky PS 70-100%
- AST and ALT \< 4 times upper limit of normal
- Bilirubin \< 2.0 mg/dL (unless liver involvement)
- Creatinine within normal range for age OR creatinine clearance \> 60 mL/min/1.73 m\^2
- Adequate cardiac function (either asymptomatic with no prior risk factors, or if symptomatic, left ventricular ejection fraction \> 50% at rest)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled viral, bacterial, or fungal infection
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior clofarabine
- More than 2 weeks since prior systemic chemotherapy
- At least 7 days since prior chemotherapy for patients with rapidly progressive disease and recovered
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00462787
Start Date
April 1 2007
End Date
November 1 2013
Last Update
November 14 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065